Non-invasive systems and methods for detecting mental impairment

ABSTRACT

A mental impairment detection system and non-invasive method of detecting mental impairment of a user are provided. A test (e.g., an inhibitory reflex test or a sustained attention test) is administered to the user, brain activity in a frontal lobe of the user is non-invasively detected while the test is administered to the user, and a level of mental impairment of the user is determined based on the brain activity detected in the frontal lobe of the user.

RELATED APPLICATION DATA

Pursuant to 35 U.S.C. § 119(e), this application claims the benefit ofU.S. Provisional Patent Application Ser. No. 62/712,141, filed Jul. 30,2018, which is expressly incorporated herein by reference.

FIELD OF THE INVENTION

The present inventions relate to methods and systems for non-invasivemeasurements in the human body, and in particular, methods and systemsrelated to detecting mental impairment.

BACKGROUND OF THE INVENTION

The operation of transportation vehicles, such as cars, motorcycles,trucks, and airplanes, as well as the performance of high responsibilityjobs, such as air traffic controllers and heavy machinery operators(e.g., a forklift or crane), by individuals who are temporarily mentallyimpaired due to the influence of chemical substances, such as drugs(prescription or recreational) and alcohol, sleep deprivation, or braininjury (e.g., stroke or concussion) is a major problem. Not only do suchmentally impaired persons put their own lives at risk, they put innocentlives at risk as well. In addition to putting lives at risk, suchmentally impaired individuals are subject to fines, license revocationor suspension, firing or suspension from employment, and criminalprosecution.

In many cases, individuals that are temporarily mentally impaired arenot aware or are unsure of the extent of their mental impairment. Thereexists sobriety screening or monitoring systems that allow an individualto measure his or her own alcohol blood level, thereby providing suchindividual an indication of the extent of mental impairment due toalcohol consumption. However, such systems only measure the level ofalcohol content, and do not actually measure the level of impairment, ofthe individual being tested, and thus, may not accurately determine theability of the individual to operate transportation vehicles or performhigh responsibility jobs. For example, alcohol tolerance levels may varygreatly amongst individuals, and more importantly, individuals with lowalcohol tolerance levels may actually be mentally impaired to the extentthat operating transportation vehicles or performing high responsibilityjobs would be considered unsafe despite the fact the blood alcohol levelof such individuals may indicate that they are not so impaired.Furthermore, such sobriety screening systems do not take into accountnon-alcoholic causes of temporary mental impairment or other variouslevels of mental impairment, such as prescription or recreational drugs,as well as pre-existing medical conditions caused by disease or injurythat may mentally impair an individual that is not under the influenceof alcohol.

There, thus, remains a need to determine the level that an individual isactually impaired with respect to operating transportation vehicles orperforming high responsibility jobs.

SUMMARY OF THE INVENTION

In accordance with one aspect of the present inventions, a mentalimpairment detection system comprises a sensory stimulation device(e.g., a display device) configured for administering a test to a userthat evokes a process in a frontal lobe (e.g., in a premotor cortex ordorsolateral prefrontal cortex) of the user, a non-invasive braininterface assembly configured for detecting brain activity in thefrontal lobe of the user while the test is administered to the user, andat least one processor configured for determining a level of mentalimpairment of the user based on the brain activity detected in thefrontal lobe of the user. In one embodiment, the mental impairmentdetection system further comprises a communication device (e.g., atleast one speaker) configured for instructing the user how to performthe test.

In one embodiment, the processor(s) is configured for determining thelevel of mental impairment of the user by quantifying results of thetest administered to the user based on the brain activity detected inthe frontal lobe of the user, e.g., by further comparing the quantifiedresults of the test administered to the user to baseline quantifiedresults of the test administered to the user when the user is known tonot be mentally impaired. In another embodiment, the mental impairmentdetection system further comprises a camera configured for tracking headmovements of the user, wherein the at least one processor is configuredfor determining the level of impairment of the user further based on thetracked head movements of the user. In still another embodiment, thesensor stimulation device is further configured for administering areflex test to the user, in which case, the non-invasive brain interfaceassembly may be further configured for detecting brain activity in anon-frontal lobe of the user while the reflex test is administered tothe user, and the processor(s) may be configured for determining thelevel of impairment of the user further based on the brain activitydetected in the non-frontal lobe of the user. The non-invasive braininterface assembly may, e.g., one of an optical measurement assembly anda magnetic measurement assembly, and may, e.g., comprise at least onesensor configured for detecting energy from a brain of the user, andprocessing circuitry configured for identifying the brain activity inresponse to detecting the energy from the brain of the user. Thenon-invasive brain interface assembly may comprise, e.g., a head-wornunit carrying the sensor(s), and a computer containing the processor(s).

In accordance with another aspect of the present inventions, anon-invasive method of detecting mental impairment of a user comprisesadministering a test to the user (e.g., via displaying) that evokes aprocess in a frontal lobe (e.g., in a premotor cortex or dorsolateralprefrontal cortex) of the user, non-invasively detecting brain activityin the frontal lobe of the user (e.g., optically detecting the brainactivity of the user and magnetically detecting the brain activity ofthe user) while the test is administered to the user, and determining alevel of mental impairment of the user based on the brain activitydetected in the frontal lobe of the user. The method may furthercomprise instructing the user how to take the test.

In one method, determining the level of mental impairment of the usercomprises quantifying results of the test administered to the user basedon the brain activity detected in the frontal lobe of the user, e.g., byfurther comparing the quantified results of the test administered to theuser to baseline quantified results of the test administered to the userwhen the user is known to not be mentally impaired. Another methodfurther comprises tracking head movements of the user, wherein the levelof impairment of the user is further based on the tracked head movementsof the user. Still another method further comprises administering areflex test to the user, and detecting brain activity in a non-frontallobe of the user while the reflex test is administered to the user. Inthis case, the level of impairment of the user may be determined furtherbased on the brain activity detected in the non-frontal lobe of theuser.

The test administered to the user may be an inhibitory reflex test. Inone embodiment, the inhibitory reflex test comprises an anti-saccadetask. In this case, displaying the inhibitory reflex test may comprisedisplaying a motionless target in a center of a field of vision of theuser, and subsequently displaying a first visual stimulus in a peripheryof the field of vision of the user. The user may be instructed to fixateon the motionless target, and to make a saccade in a direction away fromthe first visual stimulus when the first visual stimulus is displayed inthe periphery of the field of vision of the user. The inhibitory reflextest may further comprise a saccade task. In this case, displaying theinhibitory reflex test further comprises randomly or pseudo-randomlydisplaying the first visual stimulus or a second visual stimulusdifferent from the first visual stimulus one at a time in the peripheryof the field of the vision of the user, in which case, the user may beinstructed to make a saccade in a direction towards the second visualstimulus when the second visual stimulus is displayed in the peripheryof the field of vision of the user. The level of impairment of the usermay be determined by determining either a reaction time or an error ofthe user in response to the anti-saccade task. In another embodiment,the inhibitory reflex test comprises go/no-go tasks.

Alternatively, the test administered to the user may be a sustainedattention test to the user comprises displaying the sustained attentiontest to the user. In one embodiment, the sustained attention testcomprises a psychomotor vigilance task. In this case, displaying thesustained attention test may comprise randomly or pseudo-randomlypresenting a visual stimulus every few seconds over a period of time.The communication device may be configured for instructing the user toperform an action in response to each stimulus. In another embodiment,the sustained attention test comprises go/no-go tasks. In this case,displaying the sustained attention test may comprise randomly orpseudo-randomly presenting different types of stimuli one-at-a-time. Inanother embodiment, the inhibitory reflex test comprises go/no-go tasks.In this case, displaying the sustained attention test may compriserandomly or pseudo-randomly presenting different types of stimulione-at-a-time. The user may be instructed to perform an action if onetype of stimulus is presented to the user, and to not perform the actionif another different type of stimulus is presented to the user.

Other and further aspects and features of the invention will be evidentfrom reading the following detailed description of the preferredembodiments, which are intended to illustrate, not limit, the invention.

BRIEF DESCRIPTION OF DRAWINGS

The drawings illustrate the design and utility of embodiments of thepresent invention, in which similar elements are referred to by commonreference numerals. In order to better appreciate how the above-recitedand other advantages and objects of the present inventions are obtained,a more particular description of the present inventions brieflydescribed above will be rendered by reference to specific embodimentsthereof, which are illustrated in the accompanying drawings.

Understanding that these drawings depict only typical embodiments of theinvention and are not therefore to be considered limiting of its scope,the invention will be described and explained with additionalspecificity and detail through the use of the accompanying drawings inwhich:

FIG. 1 is a top view of a head of a person, particularly illustratingsensors used by a non-invasive mental impairment detection systemconstructed in accordance with one embodiment of the present inventionsto detect brain activity from the pre-motor cortex of a user;

FIG. 2A is a diagram illustrating an inhibitory reflex text administeredto a user by the mental impairment detection system, particularlyshowing a motionless target on which the user fixates;

FIG. 2B is a diagram illustrating an inhibitory reflex text administeredto a user by the mental impairment detection system, particularlyshowing a pro-saccade task performed by the user;

FIG. 2C is a diagram illustrating an inhibitory reflex text administeredto a user by the mental impairment detection system, particularlyshowing an anti-saccade task performed by the user;

FIGS. 3A and 3B are diagrams illustrating a pro-saccade task and ananti-saccade task and plans generated by the pro-motor cortex of theuser to perform the pro-saccade task and anti-saccade task;

FIG. 4A is a bar diagram illustrating an exemplary first saccadeaccuracy of the performance of pro-saccade tasks in an inhibitory reflextest administered by the mental impairment detection system to the userwhen the user is not mentally impaired and when the user is mentallyimpaired, and an exemplary first saccade accuracy of the performance ofanti-saccade tasks in an inhibitory reflex test administered by themental impairment detection system to the user when the user is notmentally impaired and when the user is mentally impaired;

FIG. 4B is a bar diagram illustrating an exemplary saccade latency ofthe performance of pro-saccade tasks in an inhibitory reflex testadministered by the mental impairment detection system to the user whenthe user is not mentally impaired and when the user is mentallyimpaired, and an exemplary saccade latency of the performance ofanti-saccade tasks in an inhibitory reflex test administered by themental impairment detection system to the user when the user is notmentally impaired and when the user is mentally impaired;

FIG. 5 is a front view of a head of a person, particularly illustratingsensors used by non-invasive mental impairment detection systemconstructed in accordance with one embodiment of the present inventionsto detect brain activity from the dorsal lateral prefrontal cortex(DLPFC) of a user;

FIG. 6 is a pictorial diagram of the non-invasive mental impairmentdetection system;

FIG. 7A is a flow diagram illustrating one method performed by thenon-invasive mental impairment detection system to detect mentalimpairment in the user using an inhibitory reflex test;

FIG. 7B is a flow diagram illustrating one method performed by thenon-invasive mental impairment detection system to detect mentalimpairment in the user using a reflex test in addition to the inhibitoryreflex test performed in the method of FIG. 7A;

FIG. 7C is a flow diagram illustrating one method performed by thenon-invasive mental impairment detection system to detect mentalimpairment in the user by tracking head movements of the user inaddition to the inhibitory reflex test performed in the method of FIG.7A;

FIG. 8 is a pictorial diagram of a virtual radial menu used by anon-invasive spatial attention control system that allows a user tospatially control the virtual radial menu via mind control;

FIG. 9 is a pictorial diagram of a driving scenario generated by anon-invasive driving simulation system that trains a user to optimizeconcentration on a road; and

FIG. 10 is a diagram of an amplitude of brain activity detected by anon-invasive attention/distraction prediction system as a function ofattention of a user on a road.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The non-invasive impairment detection system described herein is capableof determining a level of mental impairment of an individual bymeasuring the executive response inhibition of that individual to astimulus. When functioning properly, the executive response inhibitionrapidly cancels motor activity even after its initiation, and thus, issignificantly impacted by mental impairment of that individual. Incontrast to a reflexive response (e.g., patellar reflex), which involvesa bottom-up mechanism in the body that does not engage the executivebrain function of an individual, and thus is not significantly impactedby mental impairment of that individual, the non-invasive impairmentdetection system described herein focuses on an inhibitory reflexresponse, which involves a top-down mechanism in the body that doesengage the executive brain function of the individual. As such, it isbelieved that measuring the inhibitory reflex response of an individualprovides a good indication of whether or not the top-down mechanism ofthe individual is properly operating, thereby providing a robust andaccurate means of measuring the mental impairment of the individualunder a variety of different conditions, including the influence ofchemical substances, such as drugs (prescription or recreational) andalcohol, sleep deprivation, or brain injury (e.g., stroke orconcussion).

To this end, the non-invasive impairment detection system describedherein presents an inhibitory reflex test to a user, non-invasivelydetects brain activity in the frontal lobe of the user while the userperforms the inhibitory reflex test, and determines the level of mentalimpairment of the user based on the brain activity detected in thefrontal lobe of the user.

In the preferred embodiment of the non-invasive impairment detectionsystem, the brain activity of the premotor cortex in the frontal lobe ofthe user is bilaterally measured (e.g., with sensor 1 and sensor 2), asillustrated in FIG. 1. The premotor cortex is an area of the motorcortex within the frontal lobe of the brain just anterior to the primarymotor cortex (top front of the head), and is believed to play a role inplanning sensory guided movement that is subsequently executed by theprimary motor cortex. Different sub-regions of the premotor cortex havedifferent properties and presumably emphasize different functions. Thebrain signals generated in the premotor cortex cause much more complexpatterns of movement than the discrete patterns generated in the primarymotor cortex.

The inhibitory reflex test can take many forms; however, in thepreferred embodiment of the non-invasive impairment detection system,the inhibitory reflex test comprises at least one anti-saccade task toevoke anti-saccadic eye movements of the user, and at least onepro-saccade task to evoke saccadic eye movements of the user. A saccadeis a rapid, simultaneous, movement of both eyes that abruptly change thepoint of fixation of an individual. The inhibitory reflex test in thiscase is administered by displaying a motionless target 2 in the field ofview of the user, as illustrated in FIG. 2A, instructing the user tofixate on the motionless target 2, randomly presenting different visualstimuli 4 a, 4 b (e.g., having different colors) one-at-a-time in theperiphery of the field of view of the user, and instructing the user,before any stimuli are presented, to move his or her eyes towards theperipheral visual stimulus 4 a only when presented to the user(pro-saccade task), as illustrated in FIG. 2B, and opposite or 180degrees away from the peripheral visual stimulus 4 b (anti-saccade task)only when presented to the user, as illustrated in FIG. 2C.

The pro-saccade task is naturally reflexive (i.e., the bottom-upreflexive process is engaged) and will produce fast eye movements (shortreaction times) with little to no errors (incorrect eye movements awayfrom the visual stimulus) from the user, whereas the anti-saccade taskrequires the user to inhibit or suppress his or her reflexive desire tolook towards the visual stimulus (i.e., the top-bottom inhibitoryprocess is engaged), resulting in slower eye movements (longer reactiontimes) and more errors (incorrect eye movements towards the visualstimulus).

The brain signals that are sensed in the premotor cortex of the userduring the administration of the inhibitory reflex test revealsub-threshold premotor signals that are building to elicit eyemovements. For example, as illustrated in FIG. 3A, during thepro-saccade task (when the user is instructed to look towards the visualstimulus), a clear and strong primary neural signal 6 a in the premotorcortex that represents a plan of action to look towards the peripheralstimulus 4 a, builds and surpasses, at time t₁, a much weaker secondaryneural signal 6 b in the premotor cortex that represents a plan ofaction to look away from the peripheral stimulus 4 a, eventuallytriggering eye movements towards the peripheral stimulus 4 a. Incontrast, as illustrated in FIG. 3B, during the anti-saccade task (whenthe user is instructed to look away from the visual stimulus), thetop-down inhibitory process is engaged to plan an action to look awayfrom the peripheral stimulus 4 b, thereby suppressing the normallystronger primary neural signal 6 a representing the plan of action tolook towards the peripheral stimulus 4 b, at time t₁, and facilitatingthe normally weaker secondary neural signal 6 b representing the plan ofaction to look away from the peripheral stimulus 4 b to surpass theprimary neural signal 6 a, at time t₂, eventually triggering eyemovements away from the peripheral stimulus 4 b.

The manifestation of the neural signals 6 a, 6 b (shown in FIG. 3B)occurs prior to eye movements, and thus, provides insight into the eyemovements prior to actual movement of the eyes. When an individual ismentally impaired, his or her ability to suppress the primary neuralsignal 6 a during the anti-saccade task is significantly compromised.Thus, the secondary neural signal 6 b (i.e., the signal resulting fromthe top-down inhibitory process that suppresses the normally strongprimary signal 6 b) reveals attenuated neural dynamics that struggle toengage top-down inhibitory process, and therefore, elicit erroneousbehavior. In contrast, the primary neural signal 6 a (shown in FIG. 3A)measured during the pro-saccade task will not be significantlycompromised when an individual is mentally impaired.

Thus, it can be appreciated from the foregoing that the differencebetween pre-motor responses of an individual when not mentally impairedand when mentally impaired will be very similar during the performanceof a pro-saccade task, but will significantly be different during theperformance of an anti-saccade task. Over a period of time when aninhibitory reflex test comprising many pro-saccade tasks andanti-saccade tasks is performed on an individual, bi-modal measurements(pro-saccade and anti-saccade) of the individual can be quantified. Forexample, the bi-modal measurements for an individual can be quantifiedin terms of both accuracy (errors) for an individual when not mentallyimpaired (baseline) and for the same individual when mentally impaired(FIG. 4A), and reaction time for an individual when not mentallyimpaired (baseline) and for the same individual when mentally impaired(FIG. 4B). As shown in FIG. 4A, the first saccade accuracy (shown aspercentage accuracy) for the individual when performing pro-saccadetasks is virtually 100 percent for both the non-mentally impaired caseand the mentally impaired case. In stark contrast, as also shown in FIG.4A, the first saccade accuracy for the individual when performinganti-saccade tasks is about 85 percent in the non-mentally impairedcase, and 60 percent in the mentally impaired case. As shown in FIG. 4B,the saccade latency for the individual when performing pro-saccade tasksis 150 ms for both the non-mentally impaired case and the mentallyimpaired case. In stark contrast, as also shown in FIG. 4B, the saccadelatency for the individual when performing anti-saccade tasks is about225 ms in the non-mentally impaired case, and 275 ms in the mentallyimpaired case.

Thus, it can be appreciated that measurements (either or both firstsaccade error and saccade latency) taken when an individual isperforming anti-saccade tasks can be compared to baseline measurements(when the individual is not mentally impaired) to ascertain the currentlevel of mental impairment of the individual.

Although the inhibitory reflex test has been described in terms ofpro-saccade tasks and anti-saccade tasks, an inhibitory reflex test maycomprise other types of tasks, such as go/no-go tasks, which measuresthe capacity of an individual for sustained attention and responsecontrol. In this case, the brain activity of the dorsal lateralprefrontal cortex (DLPFC) in the frontal lobe of the user is bilaterallymeasured, as illustrated in FIG. 5. The DLPFC is an area in theprefrontal cortex of the brain (in the forehead), and is believed toplay a role in sustained attention. The DLPFC responds to increasedworking memory demand on both go and no-go tasks, and is thought to beinvolved in accessing sustained task information, alerting, or autonomicchanges when cognitive demands increase. Without this function, the userwould lack response inhibition.

Each stimulus of this type of inhibitory reflex test either indicates a“Go” task or a “No-Go” task. The inhibitory reflex test in this case isperformed by randomly or pseudo-randomly presenting (e.g., auditory,visual, or tactile) different stimuli (e.g., different colors or soundsor vibrations) one-at-a-time to the user, and instructing the user,before any stimuli are presented, to perform an action (e.g., moving aforefinger) if a “Go” stimulus is presented to the user, and to notperform the action (e.g., by not moving a forefinger) if a “No-Go”stimulus is presented to the user.

When an individual is mentally impaired, his or her ability to focus issignificantly compromised. Thus, a neural signal resulting from atop-down inhibitory process that suppresses a plan to perform thedesignated action (moving a forefinger) reveals attenuated neuraldynamics that struggle to engage top-down inhibitory process that resultin errors (i.e., performing the designated action when presented with a“No-Go” stimulus. Furthermore, the working memory of the individual,which can be assessed from the DLPFC and frontal eye fields (pre-motorcortex) is also compromised, and will cause errors on the no-go tasks,as well as compromised inhibitory reflex. The difference betweenpre-motor responses of an individual when not mentally impaired and whenmentally impaired will be significantly different during the performanceof the no-go task. Thus, it can be appreciated that measurements takenwhen an individual is performing go/no-go tasks can be compared tobaseline measurements (when the individual is not mentally impaired) toascertain the current level of mental impairment of the individual.

In another embodiment, rather than instructing the user to performinhibitory reflex tasks, the user may be instructed to performsustained-attention tasks that do not require inhibitory reflexfunctions. For example, the user may be instructed to perform apsychomotor vigilance task (PVT), which is a sustained-attention,reaction-timed task that measures the speed with which an individual mayrespond to a visual stimulus. In this case, the brain activity of theDLPFC of the user is bilaterally measured, as previously illustrated inFIG. 5. The sustained-attention test in this case is performed byrandomly or pseudo-randomly presenting a visual stimulus every fewseconds over a period of time (e.g., 5-10 minutes), and instructing theuser, before any stimuli are presented, to perform an action (e.g.,moving a forefinger) in response to each stimulus. Research indicatesthat mental impairment of an individual (such as lack of sleep or sleepdeficit) correlates with deteriorated alertness, slower problem-solving,declined psycho-motor skills, and increased rate of false responding.The purpose of the PVT is to measure sustained attention. The result ofthis sustained attention test can be quantified as a numerical measureof the number of false responses (i.e., the number of times thedesignated action is performed in response to no stimulus).

The mental impairment detection system described herein can performsupplemental measurements of the user in additional to the inhibitoryreflex test (or alternatively, sustained attention test) describedabove. For example, the mental impairment detection system canadditionally track head movements of the user to provide insight towardsabnormal vestibular movements that can be correlated to mentalimpairments, such as drug and/or alcohol impairments, and determine thelevel of mental impairment of the user further based on these trackedhead movements. As in the cases described above, the tracked headmovements may be compared to a baseline measurement of head movementsacquired when it is known that that the user is not mentally impaired,to determine whether or not the user is currently mentally impaired.

As another example, the mental impairment detection system canadditionally administer a reflex test in the form of a sensory stimulus(e.g., visual, auditory, or tactile) to the user, and detect brainactivity in one of the reflex circuits in the brain of the user inresponse to a sensory stimulus, and determine the level of mentalimpairment of the user further based on the detected reflex activity.Such reflex circuits may include, e.g., reflex loops between theparietal lobe and motor cortex, somatosensory cortex, auditory cortex,and frontal regions of the brain that influence eye movements, handmovements, touch, coordination, etc., or frontal loops carrying auditorysignals or visual signals to the DLPFC. As in the cases described above,the detected reflex circuits may be compared to a baseline measurementof the reflex circuits acquired when it is known that that the user isnot mentally impaired, to determine whether or not the user is currentlymentally impaired.

Referring now to FIG. 6, a generalized embodiment of a non-invasivemental impairment system 10 constructed in accordance with the presentinventions will be described. The non-invasive mental impairment system10 is configured for administering an inhibitory reflex test (oralternatively a sustained attention test) to a user 12, e.g., one ormore of the inhibitory reflex tests (or sustained attention tests)described above, detecting brain activity in the frontal lobe of theuser 12 (e.g., in the pre-frontal cortex or DLPFC) while the user 12performs the inhibitory reflex test (or sustained attention tests), anddetermining a level of mental impairment of the user 12 based on thebrain activity detected in the frontal lobe of the user 12.

To this end, the non-invasive mental impairment system 10 comprises anon-invasive brain interface assembly 14 configured for detecting brainactivity of a user 12. The non-invasive brain interface assembly 14comprises a plurality of sensors 18 configured for being placed on ornear the head of the user 12 with access to the top front (premotorcortex) and/or forehead (DLPFC) of the user 12, as respectivelyillustrated in FIGS. 1 and 5. The sensors 18 may detect the neural datasignals at a reasonably fast sample rate, e.g., 100 Hz or more.

In the preferred embodiment, the brain interface assembly 14 has aform-factor that is portable and easily worn on the head of user 12 foruse in a normal life or work environment, while using high fidelityprocesses to acquire high quality neural signals with high spatialresolution from the user. In this case, the brain interface assembly 14comprises a support structure 16 configured for being worn on the headof the user 12. The sensors 18 are arranged on the support structure 16,such that the sensors 18 are disposed around the head of the user 12.The support structure 16 may be shaped, e.g., have a headband, cap,helmet, beanie, other hat shape, or other shape adjustable andconformable to the head of the user 12. Further details discussingdifferent form factors of brain interface assemblies are set forth inU.S. Provisional Patent Application Ser. No. 62/829,124, entitled“Modulation of Mental State of a User Using a Non-Invasive BrainInterface System and Method,” and U.S. Non-Provisional Ser. No.16/364,338, entitled “Biofeedback for Awareness and Modulation of MentalState Using a Non-Invasive Brain Interface System and Method,” which areboth expressly incorporated herein by reference.

The non-invasive brain interface assembly 14 can be programmed tospecifically target brain activity in the pre-motor cortex or DLPFC ofthe frontal region of the brain of the user 12, e.g., activating certainones of the sensors 18 covering the pre-motor cortex or DLPFC.Alternatively, the brain interface assembly 14 may be specificallydesigned, such that only sensors 18 that cover the pre-motor cortex orDLPFC are disposed on the support structure 16 in the regionscorresponding to the pre-motor cortex or DLPFC. The brain interfaceassembly 14 can also be programmed or specifically designed to targetbrain activity in other regions of the brain, e.g., when detectingreflex activity in response to the presentation of a reflex test to theuser 12.

In an alternative embodiment, an extendable arm (not shown) carrying thesensors 18 may release from the head rest of a vehicle and sitcomfortably on the head of the user 12 (in this case, the driver). Inanother alternative embodiment, the sensors 18 may be embedded in theceiling and side walls of the vehicle that have a field of view to thehead of the user (driver) 12.

In any event, the brain interface assembly 14 is preferably anoptically-based non-invasive brain interface assembly, in which case,the sensors 18 may comprise, e.g., a single photon avalanche diode(SPAD) array, avalanche photodiode array, metal semiconductor photodiodearray, etc., and may be associated with pulsed, chirped, or continuouswave light sources, or a magnetically-based non-invasive brain interfaceassembly, in which case, the sensors 18 may comprise, e.g., an atomicvapor cell, nitrogen vacancy diamond, or giant magnetoresistance.

Optically-based non-invasive brain interface assemblies may, e.g.,incorporate any one or more of the neural activity detectiontechnologies described in U.S. patent application Ser. No. 15/844,370,entitled “Pulsed Ultrasound Modulated Optical Tomography Using Lock-InCamera” (now U.S. Pat. No. 10,335,036), U.S. patent application Ser. No.15/844,398, entitled “Pulsed Ultrasound Modulated Optical TomographyWith Increased Optical/Ultrasound Pulse Ratio” (now U.S. Pat. No.10,299,682), U.S. patent application Ser. No. 15/844,411, entitled“Optical Detection System For Determining Neural Activity in Brain Basedon Water Concentration,” U.S. patent application Ser. No. 15/853,209,entitled “System and Method For Simultaneously Detecting Phase ModulatedOptical Signals” (now U.S. Pat. No. 10,016,137), U.S. patent applicationSer. No. 15/853,538, entitled “Systems and Methods For Quasi-BallisticPhoton Optical Coherence Tomography In Diffusive Scattering Media Usinga Lock-In Camera” (now U.S. Pat. No. 10,219,700), U.S. patentapplication Ser. No. 16/266,818, entitled “Ultrasound Modulating OpticalTomography Using Reduced Laser Pulse Duration,” U.S. patent applicationSer. No. 16/299,067, entitled “Non-Invasive Optical Detection Systemsand Methods in Highly Scattering Medium,” U.S. patent application Ser.No. 16/379,090, entitled “Non-Invasive Frequency Domain OpticalSpectroscopy For Neural Decoding,” U.S. patent application Ser. No.16/382,461, entitled “Non-Invasive Optical Detection System and Method,”U.S. patent application Ser. No. 16/392,963, entitled “InterferometricFrequency-Swept Source And Detector In A Photonic Integrated Circuit,”U.S. patent application Ser. No. 16/392,973, entitled “Non-InvasiveMeasurement System and Method Using Single-Shot Spectral-DomainInterferometric Near-Infrared Spectroscopy Based On OrthogonalDispersion, U.S. patent application Ser. No. 16/393,002, entitled“Non-Invasive Optical Detection System and Method Of Multiple-ScatteredLight With Swept Source Illumination,” U.S. patent application Ser. No.16/385,265, entitled “Non-Invasive Optical Measurement System and Methodfor Neural Decoding,” U.S. Provisional Patent Application Ser. No.62/722,152, entitled “Time-Of-Flight Optical Measurement And Decoding OfFast-Optical Signals,” U.S. Provisional Patent Application Ser. No.62/781,098, entitled “Detection Of Fast-Neural Signal UsingDepth-Resolved Spectroscopy,” U.S. patent application Ser. No.16/226,625, entitled “Spatial and Temporal-Based Diffusive CorrelationSpectroscopy Systems and Methods,” U.S. Provisional Patent ApplicationSer. No. 62/772,584, entitled “Diffuse Correlation SpectroscopyMeasurement Systems and Methods,” U.S. patent application Ser. No.16/432,793, entitled “Non-Invasive Measurement Systems withSingle-Photon Counting Camera,” U.S. Provisional Patent Application Ser.No. 62/855,360, entitled “Interferometric Parallel Detection UsingDigital Rectification and Integration”, U.S. Provisional PatentApplication Ser. No. 62/855,380, entitled “Interferometric ParallelDetection Using Analog Data Compression,” and U.S. Provisional PatentApplication Ser. No. 62/855,405, entitled “Partially BalancedInterferometric Parallel Detection,” which are all expresslyincorporated herein by reference.

If the optically-based non-invasive brain interface assembly comprises aSPAD system, it may, e.g., incorporate any one or more of the neuralactivity detection technologies described in U.S. Non-Provisional patentapplication Ser. No. 16/051,462, entitled “Fast-Gated PhotodetectorArchitecture Comprising Dual Voltage Sources with a SwitchConfiguration” (now U.S. Pat. No. 10,158,038), U.S. patent applicationSer. No. 16/202,771, entitled “Non-Invasive Wearable Brain InterfaceSystems Including a Headgear and a Plurality of Self-ContainedPhotodetector Units Configured to Removably Attach to the Headgear” (nowU.S. Pat. No. 10,340,408), U.S. patent application Ser. No. 16/283,730,entitled “Stacked Photodetector Assemblies,” and U.S. Provisional PatentApplication Ser. No. 62/844,107, entitled “Power-Efficient Architecturefor Time-Correlated Single Photon Counting,” which are all expresslyincorporated herein by reference.

Magnetically-based non-invasive brain interface assemblies may, e.g.,incorporate any one or more of the neural activity detectiontechnologies described in U.S. Provisional Patent Application Ser. No.62/689,696, entitled “Magnetic Field Measurement Systems and Methods ofMaking and Using,” U.S. Provisional Patent Application Ser. No.62/732,327, entitled “Variable Dynamic Range Optical Magnetometer andMethods of Making and Using”, U.S. Provisional Patent Application Ser.No. 62/741,777, entitled, “Integrated Gas Cell and Optical Componentsfor Atomic Magnetometry and Methods for Making and Using,” U.S.Provisional Patent Application Ser. No. 62/752,067, entitled “MagneticField Shaping Components for Magnetic Field Measurement Systems andMethods for Making and Using,” U.S. patent application Ser. No.16/213,980, entitled “Systems and Methods Including Multi-Mode Operationof Optically Pumped Magnetometer(S),” U.S. Provisional PatentApplication Ser. No. 62/732,791, entitled “Dynamic Magnetic Shieldingand Beamforming Using Ferrofluid for Compact Magnetoencephalography(MEG),” U.S. Provisional Patent Application Ser. No. 62/796,958,entitled “Optically Pumped Magnetometer with Amplitude-SelectiveMagnetic Shield,” and U.S. Provisional Patent Application Ser. No.62/804,539, entitled “Neural Bandpass Filters for Enhanced Dynamic RangeMagnetoencephalography (MEG) Systems and Methods,” which are allexpressly incorporated herein by reference.

Optically-based or magnetically-based non-invasive brain interfaceassemblies should be contrasted with electroencephalography (EEG) orfunctional magnetic resonance imaging (fMRI) brain interface assembliesthat are limited in their form factor and have limitations on spatialresolution, and thus, currently cannot effectively acquire neuralsignals from the user 12 in a normal life or work environment.

In particular, fMRI requires large magnets enclosed within a tunneltube-type enclosure that patients lie within (similar to magneticresonance imaging (MRI) machines) which are known to causeclaustrophobia, and thus, cannot be scaled to wearable or portable formfactors. EEG does not provide spatial information and is susceptible tonoise and artifacts from the skull and other brain tissue (e.g., if theuser wiggles his or her eyebrows, blinks, or performs any number ofother movements in a vehicle). Furthermore, an EEG-based brain interfaceassembly is difficult to interface or coupled with the brain. Forexample, in order to obtain a signal, EEG electrodes require the use ofa “conductive gel,” since the electrodes need to be “wet” in order tobridge the gap between skin and the EEG electrodes. Also, in order tohave an effective EEG recording, the EEG electrodes are required to bein direct contact with the user's skull. Also, users typicallyexperience pressure and discomfort when wearing an EEG-based braininterface assembly, and removal of the gel from user's hair oftenrequires a special washing solution since the gel is known to have anadhesive effect on the hair and skull.

The non-invasive mental impairment system 10 further comprises a sensorystimulation device 20 configured for administering the inhibitory reflextest to the user 12. In the preferred embodiment, the sensorystimulation device 20 comprises a display device configured fordisplaying the inhibitory reflex test to the user 12. In the illustratedembodiment, the display device 20 comprises a head mounted display(HMD), such as, e.g., virtual reality (VR) glasses. Alternatively, thedisplay device 20 may comprise a heads-up display unit, a windshield ona car on which the inhibitory reflex test is displayed by a projectorbuilt into the dashboard of the car, an infotainment center of thevehicle, etc.

The non-invasive mental impairment system 10 further comprises acommunications device 22 configured for communicating instructions forthe inhibitory reflex test to the user 12. In the preferred embodiment,the communications device 22 comprises one or more speakers, e.g.,headphones or earbuds, that auditorily communicates the instructions forthe inhibitory reflex test to the user 12. The non-invasive mentalimpairment system 10 further comprises an optional camera 24 configuredfor tracking head movements of the user 12. The camera 24 can bediscreetly placed anywhere in a vehicle, so as to not obstruct the fieldof view of the user (driver) 12.

The non-invasive mental impairment system 10 further comprises acomputer 26 (e.g., a Smartphone, tablet computer, or the like)configured for administering the inhibitory reflex test by sendingsignals to the sensory stimulation device 20 to administer theinhibitory reflex test to the user 12 and to the communications device22 to communicate the instructions for taking the inhibitory reflex testto the user 12, as well as storing and analyzing the informationacquired by the brain interface assembly 14 to ultimately determine alevel of mental impairment of the user 12. The computer 26 determinesthe level of the mental impairment of the user 12 by quantifying theresults of the inhibitory reflex test taken by the user 12, effectivelygrading the inhibitory reflex test, and comparing these quantifiedresults to the baseline results of the inhibitory reflex test taken bythe user 12 when known to be not mentally impaired. The manner in whichthe computer 26 quantifies the results of the inhibitory reflex testwill ultimately depend on the nature of the inhibitory reflex test.

For example, if the inhibitory reflex test comprisespro-saccade/anti-saccade tasks, the computer 26 may quantify the resultsof the inhibitory reflex test by determining the first saccade accuracy(see FIG. 4A) and/or saccade latency (see FIG. 4B) for the anti-saccadetasks performed by the user 12 over the duration of the inhibitoryreflex test. If the inhibitory reflex test comprises go/no-go tasks, thecomputer 22 may quantify the results of the inhibitory reflex test bydetermining the number of errors (the number of times user 12erroneously performs the designated action in the presence of a “No-Go”stimulus) for the No-Go tasks over the duration of the inhibitory reflextest. If the inhibitory reflex test comprises a PVT, the computer 26 mayquantify the results of the inhibitory reflex test by determining thenumber of lapses in attention of the user 12 (the number of times thedesignated action is not performed in response to a stimulus).

Any one of a variety of data models can be used to classify the resultsof the inhibitory reflex test taken by the user 12, and will highlydepend on the characteristics of brain activity that are input onto thedata models. Such characteristics of brain activity may typically beextracted from the spatiotemporal brain activity that is captured, andcan include, e.g., location of signal, fine grained pattern within oracross locations, amplitude of signal, timing of response to behavior,magnitude of frequency bands of the signal (taking the Fourier transformof the time series), ratio of magnitude of frequency bands,cross-correlation between time series of signal between two or morelocations captured simultaneously, spectral coherence between two ormore locations captured simultaneously, components that maximizevariance, components that maximize non-gaussian similarity, etc. Thecharacteristics of the brain activity can be extracted from preprocessedraw data recorded during the inhibitory reflex test. The preprocessingof the raw data typically involves filtering the data (either in thetime domain or the frequency domain) to smooth, remove noise, andseparate different components of signal. Data models can include, e.g.,support vector machines, expectation maximization techniques,naïve-Bayesian techniques, neural networks, simple statistics (e.g.,correlations), deep learning models, pattern classifiers, etc.

The data model is typically initialized with some training data (meaningthat a calibration routine can be performed on the user 12). If notraining information can be acquired, such data model can beheuristically initialized based on prior knowledge, and the data modelscan be iteratively optimized with the expectation that optimization willsettle to some optimal maximum or minimum solution. A data model thathas already been proven, for example, in a laboratory setting, can beinitially uploaded to the non-invasive mental impairment detectionsystem 10, which system will then use the uploaded data models toquantify the results of the inhibitory reflex test taken by the user 12.Optionally, the non-invasive mental impairment detection system 10 maycollect data during actual use with the user 12, which can then bedownloaded and analyzed in a separate server, for example in alaboratory setting, to create new or updated data models. Softwareupgrades, which may include the new or updated data models, can beuploaded to the non-invasive mental impairment detection system 10 toprovide new or updated data modelling and data collection.

The non-invasive mental impairment detection system 10 optionallycomprises a database, server, or cloud structure 28 configured fortracking the brain activity of the user 12. For example, the database,server, or cloud structure 28 may be configured to collect raw data(e.g., brain activity data) generated by the brain interface assembly14. Furthermore, the database, server, or cloud structure 28(independently of or in conjunction with the mental impairment functionsof the computer 26) may be configured for performing a data analysis ofthe raw data in order to determine the level of mental impairment of theuser 12.

For example, if the raw data obtained by the user 12 is being anonymizedand stored in the database, server, or cloud structure 28, the datamodels can be pooled across various users, which deep learningalgorithms would benefit from. The database, server, or cloud structure28 may be configured for performing cross-correlation analysis of thesignal data analysis in order to reduce the pool size of the databaseand focus subject averaged data to a pool that is similar to the user12. Most likely, each user 12 will have a portion of their data modeloptimized to them, but then another portion takes advantage of patternsextracted from a larger pool of users. Generalizing data models maycomprise various variabilities and optimizing may be difficult. However,by building a large user database on the database, server, or cloudstructure 28, a data analysis pipeline connected to such database,server, or cloud structure 28 can preprocess data (clean it up), extractall different kinds of features, and then apply an appropriate datamodel, to overcome this issue. Although, all of the tracked dataanalysis has been described as being performed by the database, server,or cloud structure 28, it should be appreciated that at least a portionof the tracked data analysis functionality may be incorporated in thecomputer 26, with the caveat that it is preferred that the tracking ofthe brain activity between a pool of users be performed by the database,server, or cloud structure 28.

The computer 26 may be coupled to the non-invasive brain assembly 14,display device 20, communications device 22, camera 24, and database,server, or cloud structure 28 via wired or wireless communications links(e.g., wireless radio frequency (RF) signals (e.g., Bluetooth, Wifi,cellular, etc.) or optical links (e.g., fiber optic or infrared (IR))30.

Having described the structure, function, and application of thenon-invasive mental impairment detection system 10, one method 100 a ofoperating the mental impairment detection system 10 will now bedescribed with reference to FIG. 7A. It should be appreciated that,although the method 100 a is described in the context of an inhibitoryreflex test, a method can utilize a sustained reflex test as analternative, or in addition, to the inhibitory reflex test.

First, the mental impairment detection system 10 communicates (e.g., viathe communications device 22) the rules for taking the inhibitory reflextest to the user 12 (step 102). For example, if the inhibitory reflextest comprises pro-saccade and anti-saccade tasks, the mental impairmentdetection system 10 instructs the user 12 to fixate on the motionlesstarget 2, make a saccade in a direction towards the first visualstimulus 4 a (if it has a certain characteristic, e.g., purple) and makea saccade in a direction away from the second different visual stimulus4 b (if it has a certain characteristic, e.g., red) (see FIGS. 2A-2C).

Then, the mental impairment detection system 10 administers theinhibitory reflex test by displaying the inhibitory reflex test via thesensory stimulation device 20) to the user 12 (step 104). For example,if the inhibitory reflex test comprises pro-saccade and anti-saccadetasks, the mental impairment detection system 10 randomly orpseudo-randomly displays the first and second visual 4 a, 4 b stimulione at a time in the periphery of the field of the vision of the user12.

The mental impairment detection system 10 (via the non-invasive braininterface assembly 14) then non-invasively detects brain activity in thefrontal lobe of the user 12 while the inhibitory reflex test isadministered to the user 12 (step 106). For example, if the inhibitoryreflex test comprises pro-saccade and anti-saccade tasks, brain activityin the premotor cortex of the user 12 may be non-invasively detected.

The mental impairment detection system 10 (via the computer 26) thenquantifies results of the inhibitory reflex test administered to theuser 12 based on the brain activity detected in the frontal lobe of theuser 12 (step 108). For example, if the inhibitory reflex test comprisespro-saccade and anti-saccade tasks, the mental impairment detectionsystem 10 may compute a percentage of errors and/or an average latencytime for all anti-saccade tasks performed during the administration ofthe inhibitory reflex.

Then, the mental impairment detection system 10 (via the computer 26)compares the currently quantified results of the inhibitory reflex test(i.e., the quantified results of the inhibitory reflex test currentlyadministered to the user 12) to baseline quantified results of theinhibitory reflex test (i.e., the quantified results of the inhibitoryreflex administered to the user 12 when the user 12 is known to not bementally impaired) (step 110). Such comparison function may comprisecomputing the difference between the currently quantified results of theinhibitory reflex test to the baseline quantified results of theinhibitory reflex test.

The baseline quantified results can be previously acquired byadministering the same inhibitory reflex test to the user 12 when theuser 12 is known to not be mentally impaired, i.e., communicating therules for taking the inhibitory reflex test to the user 12,administering the inhibitory reflex test to the user 12, non-invasivelydetecting brain activity in the frontal lobe of the user 12 while theinhibitory reflex test is administered to the user 12, and quantifyingthe results of the inhibitory reflex test administered to the user 12based on the brain activity detected in the frontal lobe of the user 12.

The mental impairment detection system 10 (via the computer 26) thendetermines the level of mental impairment (if any) of the user 12 basedon the comparison between the currently quantified results of theinhibitory reflex test and the baseline quantified results of theinhibitory reflex test (step 112). For example, the mental impairmentdetection system 10 may access a look-up table comprising differentreference levels of mental impairment for the user 12 correlated to arange of reference differences (i.e., differences between the quantifiedresults of the inhibitory reflex test and the baseline quantifiedresults of the inhibitory reflex test), and selecting the referencelevel of mental impairment correlated to the reference difference thatmatches the computed difference between the currently quantified resultsof the inhibitory reflex test and the baseline quantified results of theinhibitory reflex test.

The mental impairment detection system 10 may optionally confirm orsupplement the quantified results of the inhibitory reflex test used todetermine the level of mental impairment of the user 12 at step 112.

For example, one method 100 b of operating the mental impairmentdetection system 10 to supplement the quantified results of theinhibitory reflex test with quantified results of a reflex test will nowbe described with reference to FIG. 7B.

In this case, the mental impairment detection system 10 (e.g., via thecommunications device 22) may communicate the rules for taking a reflextest to the user 12 (step 114); administers the reflex test (e.g., bydisplaying the reflex test via the sensory stimulation device 20) to theuser 12 (step 116); non-invasively detects brain activity in the brainof the user 12 (via the non-invasive brain interface assembly 14) whilethe reflex test is administered to the user 12 (step 118), quantifiesthe results of the reflex test administered to the user 12 based on thebrain activity detected in the brain of the user 12 (step 120), andcompares the quantified results of the reflex test administered to theuser 12 to baseline quantified results of the reflex test administeredto the user 12 when the user 12 is known to not be mentally impaired(step 122). The mental impairment detection system 10 (via the computer26) then determines the level of mental impairment of the user 12, basedon the comparison between the currently quantified results of theinhibitory reflex test and the baseline quantified results of theinhibitory reflex test, in conjunction with or confirmed by a comparisonbetween the currently quantified results of the reflex test and thebaseline quantified results of the reflex test (step 112′).

As another example, another method 100 c of operating the mentalimpairment detection system 10 to supplement the quantified results ofthe inhibitory reflex test with quantified results of head tracking willnow be described with reference to FIG. 7C. The mental impairmentdetection system 10 (via the camera 24) may track the head movements ofthe user (step 124). The mental impairment detection system 10 may thendetermine the level of mental impairment of the user 12 based on thecomparison between the currently quantified results of the inhibitoryreflex test and the baseline quantified results of the inhibitory reflextest, in conjunction with or confirmed by any abnormal vestibularmovements that can be correlated to mental impairments of the user (step112″).

In an alternative embodiment, a non-invasive spatial attention controlsystem (FIG. 8) may be similar to the non-invasive mental impairmentdetection system 10 described above, with the exception of, instead ofdetecting mental impairment of the user 12, the spatial attentioncontrol system allows the user 12 to spatially control a virtual menumerely by envisioning the menu in the mind of the user 12 and mindcontrolling the virtual menu, thereby freeing the hands of the user toperform other tasks, while also allowing the user 12 to focus his or hereyes on objects necessary to safely perform such tasks. Thus, thespatial attention control system particularly lends itself to situationswhere the user 12 must maintain eye contact on a particular task (e.g.,looking at the road during operation of transportation vehicles, such ascars, motorcycles, and trucks; looking at a landing strip when flying anairplane; looking at air traffic as an air traffic controller, orlooking at payloads when operating heavy machinery, etc.

To this end, the user 12 envisions a specific virtual menu, such as thevirtual radial menu 50 illustrated in FIG. 8. The user 12 controls thevirtual radial menu 50, while still focusing his or her attention on thetask at hand (e.g., maintaining eye contact with the road if the user 12is driving a car), by covertly shifting his or her spatial attention inany direction depending on what functions on the virtual radial menu 50the user 12 wants to control. If, for example, the user (driver) 12 canshift his or her covert spatial attention to the right to access musicand radio channel options 52 or to the left to access temperaturecontrol 54 of the cabin. After selecting the music or radio channeloptions 52 or the temperature control 54, the user 12 can then covertlyshift his or her spatial attention to the up button 56 or the downbutton 58 to control the volume of the music or the temperature in thecabin.

The virtual radial menu 50 may be memorized by the user 12 beforehand,and therefore does not need to be displayed, or optionally can bedisplayed by the display device 20 illustrated in FIG. 6. Thenon-invasive spatial attention control system may utilize thenon-invasive brain interface assembly 14 to detect brain activity in thepre-motor cortex and/or DLPFC of the user 12, and the computer 26 and/ordatabase, server, or cloud structure 28 may extract features from thedetected brain activity correlated to the direction in which the user 12covertly shifts his or her spatial attention.

As another alternative embodiment, a non-invasive driving simulationsystem may be similar to the non-invasive mental impairment detectionsystem 10 described above, with the exception of, instead of detectingmental impairment of the user 12, the neurofeedback system trains a user(as a driver) 12 to optimize concentration on the road and provideawareness to the user 12. The display device 20 displays a drivingscenario 60 to the user 12, including a road 62 and a speedometer gauge64, as illustrated in FIG. 9. The driving simulation system may utilizethe communications device 22 illustrated in FIG. 6 to instruct the user12 to focus on the road 62 and concentrate on driving steady at aspecified posted speed limit.

The non-invasive driving simulation system may utilize the non-invasivebrain interface assembly 14 to detect brain activity in the DLPFC of theuser 12, and the computer 26 and/or database, server, or cloud structure28 may extract features from the detected brain activity correlated tothe concentration of the user 12 on the road 62 and maintaining the carsteady at the specified speed limit while viewing the speedometer gauge64. The end goal of the driving simulation system is to optimize thebrain activity of the user 12 towards concentrating on the road 62 andmaintaining the car steady at the specified speed limit. The computer 26may update the speedometer gauge 64 based on the detected brainactivity. If the brain interface assembly 14 is magnetically-based, thespeedometer gauge 64 may be updated based on the beta power or the ratioof theta to alpha power of the detected brain activity. If the braininterface assembly 14 is optically-based, the speedometer gauge 64 maybe updated based on contrast between the average time-of-flight (TOF)distribution collected across an entire session and average TOFdistributions collected during concentration on the task.

As another alternative embodiment, a non-invasive attention/distractionprediction system may be similar to the non-invasive mental impairmentdetection system 10 described above, with the exception of, instead ofdetecting mental impairment of the user 12, the attention/distractionprediction system assesses the attentional state of the user 12 (e.g., adriver) and determines if the user 12 is fully engaged with driving oris inattentive.

The attention/distraction prediction system may utilize the non-invasivebrain interface assembly 14 to detect brain activity in the pre-motorcortex and/or DLPFC of the user 12, and the computer 26 and/or database,server, or cloud structure 28 may extract features from the detectedbrain activity correlated to concentration and the level of mentalworkload that is effecting that concentration, and predict whether theuser 12 is going to shift his or her spatial attention. This can bereflected in the power spectrum of certain oscillatory bands or beanalyzed via feeding time-frequency signals into neural network machinesthat predict correlates to level of concentration, as illustrated inFIG. 10. This level can then be monitored to assess driver awareness andcorrect focus to the road if workload is becoming saturated. The powerspectrum of theta and alpha rhythms of the detected brain activity canbe monitored across time to track drowsiness and used to createpredictions prior to actual drowsiness or shifts to an inattentivestate. The attention/distraction prediction system may optionallyutilize the camera 24 to track the eyes of the user 12, such that thegaze position of the user 12 can be extracted and utilized inconjunction with the features extracted from the detected brain activityto predict if this upcoming shift of spatial attention is going to beoff of the road.

Based on this information, the attention/distraction prediction systemalerts the user 12. For example, if the attention/distraction predictionsystem determines that the user 12 is likely to shift his or her focusof the road, it can sound an alarm alerting the user 12 to focus on theroad, or alternatively, may present a visual alert at the location ofthe attention focus predicted from the neural and eye tracking signalsin order to minimize the obtrusiveness of an auditory alarm.

Although particular embodiments of the present inventions have beenshown and described, it will be understood that it is not intended tolimit the present inventions to the preferred embodiments, and it willbe obvious to those skilled in the art that various changes andmodifications may be made without departing from the spirit and scope ofthe present inventions. Thus, the present inventions are intended tocover alternatives, modifications, and equivalents, which may beincluded within the spirit and scope of the present inventions asdefined by the claims.

1. A mental impairment detection system, comprising: a sensorystimulation device configured for administering an inhibitory reflextest to a user; a non-invasive brain interface assembly configured fordetecting brain activity in a frontal lobe of the user while theinhibitory reflex test is administered to the user; and at least oneprocessor configured for determining a level of mental impairment of theuser based on the brain activity detected in the frontal lobe of theuser.
 2. The mental impairment detection system of claim 1, wherein thenon-invasive brain interface assembly is configured for detecting thebrain activity in a premotor cortex of the frontal lobe of the user. 3.The mental impairment detection system of claim 1, wherein thenon-invasive brain interface assembly is configured for detecting thebrain activity in a dorsolateral prefrontal cortex of the frontal lobeof the user.
 4. The mental impairment detection system of claim 1,wherein the sensory stimulation device comprises a display deviceconfigured for displaying the inhibitory reflex test to the user.
 5. Themental impairment detection system of claim 4, wherein the inhibitoryreflex test comprises an anti-saccade task.
 6. The mental impairmentdetection system of claim 5, wherein displaying the inhibitory reflextest comprises displaying a motionless target in a center of a field ofvision of the user, and subsequently displaying a first visual stimulusin a periphery of the field of vision of the user.
 7. The mentalimpairment detection system of claim 6, further comprising acommunication device configured for instructing the user to fixate onthe motionless target, and to make a saccade in a direction away fromthe first visual stimulus when the first visual stimulus is displayed inthe periphery of the field of vision of the user.
 8. The mentalimpairment detection system of claim 7, wherein the inhibitory reflextest further comprises a saccade task.
 9. The mental impairmentdetection system of claim 8, wherein displaying the inhibitory reflextest further comprises randomly or pseudo-randomly displaying the firstvisual stimulus or a second visual stimulus different from the firstvisual stimulus one at a time in the periphery of the field of thevision of the user, wherein the communication device is furtherconfigured for instructing the user to make a saccade in a directiontowards the second visual stimulus when the second visual stimulus isdisplayed in the periphery of the field of vision of the user.
 10. Themental impairment detection system of claim 7, wherein thecommunications device comprises at least one speaker.
 11. The mentalimpairment detection system of claim 5, wherein the at least oneprocessor is configured for determining the level of impairment of theuser by determining either a reaction time or an error of the user inresponse to the anti-saccade task.
 12. The mental impairment detectionsystem of claim 5, wherein the inhibitory reflex test comprises go/no-gotasks.
 13. The mental impairment detection system of claim 1, whereinthe at least one processor is configured for determining the level ofmental impairment of the user by quantifying results of the inhibitoryreflex test administered to the user based on the brain activitydetected in the frontal lobe of the user.
 14. The mental impairmentdetection system of claim 13, wherein the at least one processor isconfigured for determining a level of mental impairment of the user byfurther comparing the quantified results of the inhibitory reflex testadministered to the user to baseline quantified results of theinhibitory reflex test administered to the user when the user is knownto not be mentally impaired.
 15. The mental impairment detection systemof claim 1, further comprising a camera configured for tracking headmovements of the user, wherein the at least one processor is configuredfor determining the level of impairment of the user further based on thetracked head movements of the user.
 16. The mental impairment detectionsystem of claim 1, wherein the sensor stimulation device is furtherconfigured for administering a reflex test to the user, wherein thenon-invasive brain interface assembly is further configured fordetecting brain activity in a non-frontal lobe of the user while thereflex test is administered to the user, and the at least one processoris configured for determining the level of impairment of the userfurther based on the brain activity detected in the non-frontal lobe ofthe user.
 17. The mental impairment detection system of claim 1, whereinthe non-invasive brain interface assembly is one of an opticalmeasurement assembly and a magnetic measurement assembly.
 18. The mentalimpairment detection system of claim 1, wherein the non-invasive braininterface assembly comprises at least one sensor configured fordetecting energy from a brain of the user, and processing circuitryconfigured for identifying the brain activity in response to detectingthe energy from the brain of the user.
 19. The mental impairmentdetection system of claim 18, wherein the non-invasive brain interfaceassembly comprises a head-worn unit carrying the at least one sensor.20. The mental impairment detection system of claim 1, wherein thenon-invasive brain interface assembly comprises a computer containingthe at least one processor.
 21. A non-invasive method of detectingmental impairment of a user, comprising: administering an inhibitoryreflex test to the user; non-invasively detecting brain activity in afrontal lobe of the user while the inhibitory reflex test isadministered to the user; and determining a level of mental impairmentof the user based on the brain activity detected in the frontal lobe ofthe user.
 22. The non-invasive method of claim 21, wherein the brainactivity is detected in a premotor cortex of the frontal lobe of theuser.
 23. The non-invasive method of claim 21, wherein the brainactivity is detected in a dorsolateral prefrontal cortex of the frontallobe of the user.
 24. The non-invasive method of claim 21, whereinadministering the inhibitory reflex test to the user comprisesdisplaying the inhibitory reflex test to the user.
 25. The non-invasivemethod of claim 25, wherein the inhibitory reflex test comprises ananti-saccade task.
 26. The non-invasive method of claim 25, whereindisplaying the inhibitory reflex test comprises displaying a motionlesstarget in a center of a field of vision of the user, and subsequentlydisplaying a first visual stimulus in a periphery of the field of visionof the user.
 27. The non-invasive method of claim 26, further comprisinginstructing the user to fixate on the motionless target, and to make asaccade in a direction away from the first visual stimulus when thefirst visual stimulus is displayed in the periphery of the field ofvision of the user.
 28. The non-invasive method of claim 27, wherein theinhibitory reflex test further comprises a saccade task.
 29. Thenon-invasive method of claim 28, wherein displaying the inhibitoryreflex test further comprises randomly or pseudo-randomly displaying thefirst visual stimulus or a second visual stimulus different from thefirst visual stimulus one at a time, the method further comprisinginstructing the user to make a saccade in a direction towards the secondvisual stimulus when the second visual stimulus is displayed in theperiphery of the field of vision of the user.
 30. The non-invasivemethod of claim 25, wherein determining the level of impairment of theuser comprises determining either a reaction time or an error of theuser in response to the anti-saccade task.
 31. The non-invasive methodof claim 25, wherein the inhibitory reflex test comprises go/no-gotasks.
 32. The non-invasive method of claim 21, wherein determining thelevel of mental impairment of the user comprises quantifying results ofthe inhibitory reflex test administered to the user based on the brainactivity detected in the frontal lobe of the user.
 33. The non-invasivemethod of claim 32, wherein determining the level of mental impairmentof the user further comprises comparing the quantified results of theinhibitory reflex test administered to the user to baseline quantifiedresults of the inhibitory reflex test administered to the user when theuser is known to not be mentally impaired.
 34. The non-invasive methodof claim 21, further comprising tracking head movements of the user,wherein the level of impairment of the user is further based on thetracked head movements of the user.
 35. The non-invasive method of claim21, further comprising: administering a reflex test to the user; anddetecting brain activity in a non-frontal lobe of the user while thereflex test is administered to the user; wherein the level of impairmentof the user is determined further based on the brain activity detectedin the non-frontal lobe of the user.
 36. The non-invasive method ofclaim 21, wherein detecting the brain activity of the user comprises oneof optically detecting the brain activity of the user and magneticallydetecting the brain activity of the user. 37.-91. (canceled)